HIV Infections Clinical Trial
Official title:
A Couple-based Antiretroviral Therapy Adherence Intervention for People Who Inject Drugs in Kazakhstan
Verified date | April 2024 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The fastest growing HIV epidemics globally are driven by injection drug use, but only a small percentage of HIV-positive people who inject drugs (PWID) have achieved viral suppression. The proposed project will adapt a couple-based antiretroviral therapy (ART) adherence intervention for PWID and assess the feasibility and acceptability of conducting dried blood spot testing to objectively measure ART adherence as part of an intervention in a clinical setting. This project advances HIV intervention science by providing an intervention that leverages social support within the dyad to improve ART adherence among PWID, which could lead to increased viral suppression, thus decreasing HIV transmission and HIV-related morbidity and mortality.
Status | Completed |
Enrollment | 132 |
Est. completion date | March 9, 2023 |
Est. primary completion date | March 9, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Participant inclusion criteria for Phase 3: 66 couples (n=132) will participate in a randomized control trial of the adapted couple-based intervention. Couples are eligible to participate if: 1. both partners are =18 years old, 2. both identify each other as their primary sexual partner (e.g. spouse, girlfriend/boyfriend, regular sexual partner), 3. the relationship has existed at least 3 months, 4. both report feeling safe participating with their partner in the study, 5. neither reports any severe physical or sexual violence perpetrated by the other partner in the past year, 6. both are able to provide informed consent and follow study procedures, and 7. both are fluent in Russian. In addition, the "index case" (partner initially recruited from AIDS Center) must: (1) be confirmed HIV+ by the AIDS Center, (2) have been on ART at least 3 months, (3) not be virally suppressed according to the AIDS Center standard (<500 copies/ml), and (4) report injecting any drug in the past year. Participant exclusion criteria for Phase 3: Individuals who do not meet inclusion criteria or who meet any of the following criteria will be excluded from the study: 1. unable to provide informed consent, 2. unwilling or unable to participate in study procedures, 3. any condition that, in the opinion of the principal investigator and research staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives. |
Country | Name | City | State |
---|---|---|---|
Kazakhstan | Columbia University Global Health Research Center of Central Asia | Almaty |
Lead Sponsor | Collaborator |
---|---|
Columbia University | National Institute on Drug Abuse (NIDA) |
Kazakhstan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherence Rate to Antiretroviral Therapy | Electronic monitoring device measures every time the pill bottle was opened to take medication. Each day can be scored as a Yes/No. Adherence will be collected daily over a 6 month period. | Day 1 to Day 180 (daily) | |
Secondary | HIV Viral Load Level | HIV viral load level as collected through a blood draw at the AIDS Center | Baseline, 3 month follow-up, 6 month follow-up | |
Secondary | Medication Adherence Rate (Self-Report Score) | Self-reported; 3 items questionnaire asking participants how well they took their medication | Week 1 to Week 24 (weekly) | |
Secondary | Number of subjects that had access to substance use treatment | Self-reported; participants asked if and where they accessed substance use treatment | Baseline, 3 month follow-up, 6 month follow-up |
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